BioNTech SE

Recruitment

• Collaborates with both US and Global leadership members and human resources business partners to identify, assess and lead the search for extraordinary talent through conventional and if required unconventional means while ensuring a positive candidate experience.
• Develop recruiting strategies to include but not limited to posting positions, selecting social media platforms, employer branding campaigns, screening applications and leading the assessment of qualified candidates.
• Schedules interviews; oversees preparation of interview questions and other hiring and selection materials.
• Assists with the interview process, attending and conducting interviews with managers, directors, and other stakeholders. Attend career events as needed.
• Collaborate with the hiring manager and/or other human resource staff during the offer process, identifying and recommending salary ranges, incentives, start dates, and other pertinent details.
• Proactively build talent pipelines through referral generation, online sourcing, events, and sourcing campaigns for key roles and identified areas of focus. Serve as a subject matter expert to the recruiting team, hiring managers, and organizational leaders on integrating effective candidate identification methods across all markets.

Senior Manager, Talent Acquisition

Director

• Serve as the principal expert and strategic leader for medical review processes, ensuring the accurate and compliant evaluation of promotional and non-promotional materials, scientific content, and communications.
• Establish priorities that align with regulatory requirements, ethical standards, and BioNTech’s commitment to scientific excellence.
• Design, implement, and continuously refine robust medical review frameworks and SOPs.
• Lead the transformation of legacy systems into streamlined scalable processes that support BioNTech’s innovative pipeline and compliance needs.
• Build and manage agile, cross-functional workstreams to support medical review and information activities.
• Inspire, mentor, and empower a high-performing, matrixed team of medical reviewers, information specialists, and project managers.
• Act as a strategic partner to Regulatory, Legal, Compliance, Commercial, and Scientific Affairs teams, ensuring seamless communication and alignment on pipeline and marketed product strategies.
• Lead the development and delivery of scientifically accurate, high-quality medical information to healthcare professionals, patients, and internal teams.
• Stay ahead of evolving regulations, guidance, and industry standards. Lead audit readiness and risk mitigation efforts to ensure compliance and operational excellence.
• Establish and monitor key performance indicators to measure the impact and effectiveness of medical review and information services.

Director, US Medical Information – Medical Review

Product Manager

• Define and own the strategic vision for IAM and PAM platforms (e.g., SailPoint IIQ, CyberArk), ensuring alignment with BioNTech’s security goals
• Serve as the primary decision maker for all IAM/PAM initiatives, including application onboarding, process changes, and product replacements
• Evaluate platform capabilities and prioritize improvements based on business needs, compliance requirements, and emerging trends
• Oversee external service providers to ensure incidents and operational tasks meet agreed service levels and quality standards
• Make operational decisions such as patch approvals and incident prioritization to maintain system reliability and compliance
• Continuously improve IAM/PAM processes, including user provisioning, privileged account monitoring, and lifecycle management
• Collaborate across IT, security, and business teams to ensure solutions meet organizational objectives
• Provide regular performance insights to leadership and identify risks and opportunities

Associate Director – Product Owner, IAM, PAM

• Support the oncology therapeutic area by providing medical safety expertise to study management teams
• Ensure patient safety throughout the clinical trial process
• Contribute to clinical trial protocols and safety data assessment
• Ensure compliance with Good Clinical Practice (GCP) and regulatory reporting requirements
• Train and mentor Safety Physicians and Safety Scientists

Director, Safety Physician

• Define and execute Labeling strategy for global life cycle management of medicinal products in BioNTech's responsibility for Primary Reference Labeling (i.e., the Company Core Data Sheet (CCDS), US Prescribing Information (USPI) and EU CP Summary of Product Characteristics [SmPC]).
• The strategy comprises management of local market label dependencies and country label differences when the local markets identify a need to review Primary Reference at the Labeling Team level
• Build and lead cross-functional Labeling Teams
• Responsible for timely preparation of Primary Reference labeling updates following update of the CCDS or on request of competent Health Authorities
• Ensuring timely communication of updated CCDS content to local country offices for MAs in BioNTech’s responsibility
• Lead development and maintenance of regulatory processes and systems for Global Labeling
• Identify critical Regulatory Labeling issues and proactively implement activities for their resolution including leading initiatives for Labeling within GRA or across functions at BioNTech
• Act as the empowered delegate for the Head of Global Labeling as necessary

Associate Director, Global Labeling Lead

• Develop and execute Global value evidence generation plans for systematic literature reviews (SLR), indirect treatment comparisons (ITC), cost-effectiveness analyses (CEA), budget impact analyses (BIA), real-world evidence (RWE), and patient-reported outcomes (PRO) to optimize clinical development decisions across all stages of drug development
• Conduct global epidemiology literature reviews to inform multi-regional clinical trial site selection and recruitment strategies
• Provide guidance on FDA regulations related to patient-reported outcomes (PROs) and patient-focused drug development (PFDD), ensuring alignment with labeling claims
• Prepare regulatory-grade documents such as FDA/Global Regulatory briefing books for PRO Endpoint implementation, epidemiology, and pediatric investigation plans
• Lead the implementation of robust evidence synthesis strategies to support global pharmaceutical launches and reimbursement dossiers across HTA markets & Non HTA Markets like PICOS Simulation/Scoping, PICOS feasibility assessment and development JCA dossiers
• Lead the development of early advice (EA) dossiers (Country level and JSC) and actively participate in discussion with relevant stakeholders on the value of the clinical program
• Stay at the forefront of industry trends and integrate emerging methodologies into evidence synthesis plans including the use of AI in SLR/ITCs/ RWE and Global Value Evidence tool kit development
• Collaborate with key opinion leaders, including medical experts, through structured engagements like advisory boards and Delphi panels
• Develop pre-approval dossiers, launch models (CEA/BIA), tools, relevant Health Care Economic Information (HCEI) training materials to support US Account Management teams, Medical Science Liaisons, and field-based HEOR professionals
• Support other HEOR team members by reviewing their evidence generation plans, publications and offering constructive- solution oriented feedback
• Mentor HEOR fellows and early-career team members while providing constructive feedback on evidence generation plans

Director, Health Economics – Outcomes Research (HEOR)

• Responsible for audits within the APAC region.
• Ensuring audit objectives and scopes are risk based in alignment with the audit strategy.
• Coordinate and oversee audits performed by contracted auditors.
• This involves scheduling audits, selecting resources, reviewing reports, etc.
• Execution of the audit (remote or on site) as the lead auditor when the audit is not contracted.
• Ensure audit documentation and audit quality management system is completed according to procedures and established timelines.
• Act as a liaison to internal BioNTech stakeholders through all phases of the audit.
• Ensure that newly identified risks are considered for the audit strategy.
• Support development of a robust CAPA (Corrective and Preventative Action) Plan and approve the CAPA plan.
• Track CAPA and effectiveness checks to completion.

Associate Director, Audit & Inspection Management

Operations

• Execute the biomarker strategy by planning, coordinating, and overseeing biomarker sample operations throughout Phase I–IV clinical trials.
• Ensure biomarker sample collection, tracking, storage, and handling are performed in compliance with the clinical trial protocol and informed consent.
• Coordinate and integrate biomarker operational activities across cross ‑ functional teams.
• Lead the preparation, review, and submission of HGR application documents, ensuring regulatory compliance and alignment with study requirements, as well as leading the activities of biosample exportation/importation per study requirements.
• Coordinate end ‑ to ‑ end HGR submission activities across study teams, sites, and cross ‑ functional stakeholders, managing timelines, dependencies, and submission quality.
• Provide operational oversight and risk awareness for HGRAC activities to support timely approvals and minimize regulatory impact on study milestones.
• Deliver biomarker operational outputs on time and with high quality, in compliance with ICH/GCP requirements.
• Establish and manage efficient biomarker sample logistics from study start ‑ up through data delivery and study close ‑ out.
• Set up and maintain accurate tracking, reporting, and metrics for biomarker samples and related data.
• Support internal teams in the selection, contracting, and qualification of biomarker vendors and central laboratories.
• Oversee day ‑ to ‑ day biomarker vendor activities, including performance monitoring, issue management, and escalation.
• Provide sample forecasts to support resource planning and cost estimation.
• Track and manage external biomarker ‑ related costs for budgeting purposes.
• Oversee biomarker sample operations for complex, multi ‑ region studies.
• Take accountability for biomarker operational deliverables, study milestones, and program objectives.
• Contribute to or author biomarker and laboratory manuals and other relevant documentation.
• Partner with Translational Science, Clinical Operations, and other functions to identify gaps and drive process improvements.
• Support the implementation of new or improved processes, including SOPs and guidance documents.
• Act as the primary liaison with internal laboratories to ensure effective communication and information flow.
• Provide mentoring and support to new hires.

Senior Manager, Biomarker Operations

Communications

• Lead the development and execution of the integrated scientific communications strategy for assigned oncology asset(s) or franchise(s)
• Define the overarching scientific communication priorities across key milestones, including data readouts, congresses, publication milestones, regulatory events, and launch preparations
• Ensure scientific communication plans are aligned with the medical strategy, evidence generation priorities, and broader asset objectives
• Serve as the primary architect of the scientific narrative and messaging platform for the asset or disease area
• Ensure scientific messaging is evidence-based, differentiated, medically accurate, balanced, and aligned across functions and geographies
• Drive communication preparedness for major data disclosures, including pre-, during-, and post-congress communication needs
• Oversee strategic development of scientific communication deliverables, including scientific narratives, key scientific statements/messages, congress communication plans, Q&A documents for data disclosures, slide decks, and training materials for field medical teams

Scientific Communications Leader

• Accountable for the quality performance of one or more safety management team(s) (SMTs)
• Oversees safety monitoring, signal management, and the benefit-risk of assigned products
• Identifies and leads escalation, management, and communication of safety inquiries and concerns
• Ensures compliance with applicable law, global and local regulations

• Guide safety teams in developing strategies and providing expert input for new marketing authorizations (e.g., BLA, MAA)
• Oversee safety surveillance, signal detection, and risk management activities to ensure timely evaluation and mitigation of safety issues
• Ensure high-quality medical safety contributions to clinical and regulatory documents across portfolio products
• Build and lead a high-performing Safety Sciences team while fostering cross-functional collaboration and scientific excellence
• Collaborate with global teams in R&D, Clinical Development, Regulatory Affairs, Medical Affairs, and external stakeholders to align on safety strategies
• Balance resources effectively within the Safety Sciences team in partnership with Safety Strategy Leads

Senior Director, Safety Sciences Lead

• Perform and support end-to-end case processing activities for clinical trials, including intake, data entry, triage, MedDRA coding, seriousness evaluations, case approval, and safety queries
• Support case processing for post-marketing ICSRs, including monitoring spontaneous reports and other safety data sources
• Coordinate case exchanges with partners and track compliance metrics for safety reports through continuous quality control sampling
• Prepare and conduct quality reviews for SUSAR submissions, DSURs, line listings, and other periodic reports in line with global requirements
• Execute and maintain workflows such as regulatory reporting, safety inbox screening/intake, data reconciliation, or analytical report generation based on assigned responsibilities
• Maintain accurate records within the safety database and assist with system testing activities (e.g., user acceptance testing)

Safety Operations Specialist

Supply Chain

• Drive market launches for Supply Chain with focus on US
• Develop a comprehensive SCM-launch framework incl. process and organizational blueprints
• Create and implement effective launch processes and supply chain readiness plans in alignment with product lifecycle management, QA, RA and Commercial, MA and sales
• Build strong collaboration and governance frameworks with alliance partners for ADC pipeline commercialization
• Act with the SCM Launch- and Projects-team as SPOC for the different Product Teams
• Support developing O2C implementation in line with BioNTech’s standards and practices
• Maintain a deep understanding of Speciality Distribution and retail pharmacy channels
• Oversee Tech Transfers for SCM and communicate impacts on Planning and Material Management
• Provide best practices to enhance the Sales & Operations Planning (S&OP) process
• Advance drug shortage process
• Lead, mentor, and develop the SCM launch and governance team

Director, Commercial Supply Chain Readiness

• Represent Statistics in all assigned cross-functional clinical study teams and other projects
• Provide statistical guidance into clinical development plans, clinical study protocols, clinical study reports
• Work as part of a collaborative, cross-functional team
• Lead development of statistical analysis plans and TLFs, perform statistical analyses
• Oversee outsourced statistical CRO activities and deliverables
• Support and participate in the development of departmental strategies

Senior Director, Biostatistics – Oncology

• Support U.S. sales and use tax compliance, including return preparation, filings, and payments
• Assist with nexus analysis, taxability determinations, and exemption certificate management
• Support sales and use tax audits and respond to information requests
• Assist with U.S. federal and state income tax compliance, including data gathering and review
• Support income tax provision calculations under ASC 740 / IAS 12
• Prepare and review workpapers supporting taxable income, book-to-tax adjustments, tax attributes, and state apportionment
• Support treasury-related tax matters, including intercompany financing, cash repatriation, and funds flow planning
• Assist with tax analysis related to intercompany loans, interest, and withholding considerations
• Ensure intercompany invoicing processes are consistent with transfer pricing policies
• Support legal entity structuring, tax planning, business expansions, and operational changes
• Assist with process improvements, automation, and documentation of tax procedures
• Coordinate with local and global stakeholders to operationalize business changes
• Support local tax transformation projects, including process re-engineering, technology implementation, and data analytics
• Collaborate with stakeholders to identify opportunities for improvement and innovation of the local tax function
• Partner with IT & Global Tax to integrate tax systems with other business applications

Senior Manager, Talent Acquisition

Director, US Medical Information – Medical Review

Associate Director – Product Owner, IAM, PAM

Director, Safety Physician

Associate Director, Global Labeling Lead

Director, Health Economics – Outcomes Research (HEOR)

Associate Director, Audit & Inspection Management

Senior Manager, Biomarker Operations

Scientific Communications Leader

Director, Safety Physician

Senior Director, Safety Sciences Lead

Safety Operations Specialist

Director, Commercial Supply Chain Readiness

Senior Director, Biostatistics – Oncology

Manager – US Tax